Inflatable Elastomeric Pump for an Infusion Assembly

ABSTRACT

An improved elastomeric pump for an infusion assembly. The pump includes a generally cylindrical mandrel body with first end, an opposed second end, a length, an outer diameter corresponding to a first radius (R mandrel ), a central bore extending through the length, a first port extending from the outer diameter to the bore to provide a fluid passageway, a fill port and an exit port in fluid communication with the bore. The pump includes an inflatable elastomeric tube disposed concentrically about the mandrel, the tube being sealingly secured on the mandrel near the respective ends of the tube and having an original inner diameter that corresponds to a second radius (r) so that it approximately matches the outer diameter of the mandrel (R mandrel ), a length (L) less than the length of the mandrel, a wall thickness (t) such that: 
       (0.4225× r )&lt; t ≦(0.660× r ).

The present application is a Continuation application of U.S. patentapplication Ser. No. 13/755,037, filed Jan. 31, 2013, which claims thebenefit of priority from U.S. Provisional Applications No. 61/637,963filed on Apr. 25, 2012 and from No. 61/616,589 filed on Mar. 28, 2012and from No. 61/597,502 filed Feb. 10, 2012.

FIELD OF THE INVENTION

The present invention relates to liquid dispensing apparatus andpertains particularly to an improved infusion apparatus or assembly fordelivering intravenous drugs at a controlled rate to a patient.

BACKGROUND OF THE INVENTION

It is often necessary to intravenously supply patients withpharmaceutically active liquids at a controlled rate over a long periodof time. It is desirable that this be accomplished while the patient isin an ambulatory state. A few devices have been developed in the pastfor accomplishing this purpose.

The prior art devices typically include an inflatable elastomericbladder forming a liquid container and have a flow control valve ordevice and tubing for supply of the liquid to the patient. The walls ofthe bladder are forced to expand when filled with the liquid, andprovide the pressure for expelling the liquid. These prior art devicesare typically filled by hand by means of a syringe which often requirean inordinate amount of force.

Another drawback to the prior art devices is that the conventionalinflatable elastomeric bladder provides pressures and flow rates thatcan vary widely with the volume of liquid therein. Therefore, they donot have a reasonably stable pressure and flow rate over the infusionperiod. In addition, such conventional bladders frequently havedifficulty dispensing substantially all of the liquid by the end of theinfusion period. It is undesirable to have liquid remaining in thebladder.

Various materials are used for constructing conventional inflatableelastomeric bladders. For example, natural rubber is frequently used.Some construction requires several layers of material. The use ofsilicone in tube form to function as a pressurized liquid reservoir forinfusion purposes is described in, for example, U.S. Pat. No. 4,909,790which discloses an infusion device that uses tubular bladders mounted onmandrel supports with downstream restrictors to deliver uniform flowrates. Another example may be found in U.S. Pat. No. 7,704,230 whichdescribes a pressurized fluid reservoir made from a silicone tube for aninfusion system. Such references point to numerous possible combinationsof silicones, structural dimensions, filling pressures, operatingpressures, and fill volumes. However, the performance provided by thesilicone tube disclosed in U.S. Pat. No. 7,704,230 has been found to beunacceptable for use at least because of the variability in flow rateand the pressure during the infusion period and the difficultydispensing substantially all of the liquid by the end of the infusionperiod.

BRIEF SUMMARY OF THE INVENTION

The problems described above are addressed by the present inventionwhich encompasses an improved elastomeric pump for an infusion assembly.The pump includes:

(a) a mandrel having a generally cylindrical body having a first end andan opposed second end, a length, a generally uniform outer diameter thatcorresponds to a first radius (R_(mandrel)), a central bore extendingthrough the length, a first port positioned between the first end andsecond end and extending from the outer diameter to the bore to providea fluid passageway, a fill port at about the first end in fluidcommunication with the bore, and exit port at about the second end influid communication with the bore; and

(b) an inflatable tube disposed concentrically about the mandrel, thetube positioned between the first end and second end of the mandrel andcovering the first port, the tube being sealingly secured on the mandrelnear the respective ends of the tube and having an original innerdiameter that corresponds to a second radius (r) so that itapproximately matches the outer diameter of the mandrel (R_(mandrel)), alength (L) less than the length of the mandrel, a wall thickness (t)such that:

(0.4225×r)<t≦(0.660×r).

According to an aspect of the invention, the the inflatable tube furtherincludes a volume (vtube) of an elastomeric material:

v _(tube) =πL(2rt+t ²).

The elastomeric material is desirably an elastomeric silicone. Theelastomeric silicone desirably has a Shore Hardness (durometer hardness)of about 25 A to about 35 A (as initially reported by the manufacturer)and has a Shore Hardness (durometer hardness) after processing into aninflatable tube of between about 30 A and about 40 A. More desirably,the elastomeric silicone has a Shore Hardness (durometer hardness) afterprocessing into an inflatable tube of about 35 A to about 40 A.According to the present invention, the introduction of a volume ofliquid (v_(liquid)) between the mandrel and the inflatable tube expandsand pressurizes the tube such that the pump subsequently dispensessubstantially all the volume of liquid through the first port uponcontraction of the tube to substantially its original inner diameter.The volume of liquid (v_(liquid)) is determined according to thefollowing equation:

(12.50×v _(tube))≦v _(liquid)≦(22.16×v _(tube))

and it is introduced through the fill port at a fill pressure of greaterthan 0 and less than 35 psig.

The present invention also encompasses an elastomeric pump for aninfusion assembly as generally described above wherein the pumpdispenses substantially all the volume of liquid through the first port.

Generally speaking, the present invention relates to the discovery ofcertain relative ratios of tube wall thickness and liquid fill volumesthat result in specific pressure ranges for the purpose of infusing50-600 ml of liquid at relatively uniform flow rates until almost allthe liquid is expelled. According to an aspect of the invention, theexpansion of the tube to contain a given fill volume (e.g., 50-600milliliters) may be readily accomplished by manual injection from asyringe device (filling pressure upstream of the tube is less than 35psig). In another aspect of the invention, there is minimal residualvolume of liquid in the tube after expelling substantially all of theliquid (i.e. less than 4 milliliters of liquid remaining in theinflatable tube). In another aspect of the invention, delivery of atleast 60% of the fill volume of liquid is at a substantially uniformflow rate at pressures of 6.0-14.0 psig (as measured downstream of theexpanded inflatable tube). In yet another aspect of the invention, theinflatable tube is a single monolithic or homogeneous tubular material.That is, the inflatable tube desirably lacks discrete layers and is asingle extruded piece of tube. Desirably the inflatable tube is a singlemonolithic or homogenous silicone tube.

Other objects, advantages and applications of the present disclosurewill be made clear by the following detailed description of a preferredembodiment of the disclosure and the accompanying drawings whereinreference numerals refer to like or equivalent structures.

DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B are illustrations of a graph of data and informationfrom Crack Pressure and Fill Pressure testing of comparative examples ofinflatable tubes.

FIG. 2 is an illustration of a graph showing the minimum and maximumFill Pressures that are used to calculate a single Average Fill Pressurefor an exemplary improved inflatable elastomeric pump.

FIG. 3 is an illustration of a graph showing an exemplarydepressurization curve (profile) for averaged operating pressures on they-axis at averaged volumes on the x-axis for exemplary elastomeric pumpsof the invention.

FIG. 4 is an illustration of a graph showing averaged Operating Pressureprofiles for exemplary expanded tubes of exemplary elastomeric pumpsthat track their depressurization from their Fill Volumes with respectto time (Infusion Time).

FIG. 5 is an illustration of a graph showing Operating Pressure versusinfusion time as measured downstream from the inflatable tube andmandrel for four different sample sets of silicone tubes.

FIG. 6 is an illustration of a graph showing the pressure on the y-axisand the volume on the x-axis for respective pressurization anddepressurization cycles for exemplary improved inflatable elastomericpumps.

FIG. 7 is an illustration of the graph of FIG. 6 but also includingadditional information from Table 6 for Examples A-C as well as Example4.

FIG. 8 is an illustration of a graph showing a pressure curve resultingfrom the Fill values of FIG. 7 with respect to their corresponding wallthickness.

DETAILED DESCRIPTION

Reference will now be made in detail to one or more embodiments,examples of which are illustrated in the drawings. It should beunderstood that features illustrated or described as part of oneembodiment may be used with another embodiment to yield still a furtherembodiment.

The improved inflatable elastomeric pump for an infusion assembly mayhave the general configuration as described in U.S. Pat. No. 5,284,481for “Collapsible Compact Infusion Apparatus” issued Feb. 8, 1994 toSoika et al., the entire contents of which are incorporated herein byreference. Deficiencies of the elastomeric pump portion of infusionpumps discussed at column 1 of that reference are addressed by theimproved inflatable elastomeric pump as described herein.

Pressure conditions measured “upstream” or “downstream” of the inventionwill proportionally reflect conditions within the invention andspecifically will reflect expansion and contraction states of thesilicone tube. Upstream pressures characterize those pressures that acton the liquid as it is injected into the tube to expand the tube from aninitial unexpanded state to the maximum expanded state. The maximumexpanded state accommodates a Fill Volume. Because the liquid isinjected from a syringe-type device through a one-way valve connectorbefore it enters the tube, the pressure upstream of the one-way valve isdynamically measured while injection is occurring; hence these upstreampressures are greater than the pressures within the tube. (The syringedevice and especially the valve connector can act as upstream flowrestrictors and there typically is no allowance for equilibration ofpressure conditions before and after the valve connector.) Theseupstream pressures move the liquid through the valve connector, thenthrough one end of the mandrel and out the first port, and then againstthe inside surface of tube.

The measured upstream pressures ahead of the valve connector are termedCrack Pressures and Fill Pressures. The Crack Pressures indicate theforces that must be transmitted by the liquid to overcome the initialresistance to expansion of the inflatable tube. Fill Pressures indicategradual expansion of the tube between the fixed ends attached to themandrel; the expansion is in a general radial direction with respect tothe center axis of the tube. The Fill Pressures initially decrease fromthe maximum Crack Pressure and then increase to a maximum when the FillVolume is achieved. Typical measured upstream pressure data is shown inFIGS. 1A and 1B for multiple injection cycles into silicone tubes (oneinjection of 100 milliliters Fill Volume per tube). That is, FIGS. 1Aand 1B are graphs of the measure pressure of liquid in the inflatabletube versus (y-axis) for an individual injection cycle in 5 individualtubes (x-axis) (each cycle, ˜15 second in duration).

The tubes of FIGS. 1A & B all have 0.355″ ID and 3.05″ length but havedifferent wall thickness and/or durometer hardness on mandrels of thesame dimensions. As indicated on FIG. 1A: Groups A-C represent theinjection of 100 milliliters (mis or ml) into 5 individual tubes madefrom an elastomeric silicone material having a measured durometerhardness of 25 A before processing into the tubes (i.e., a 25 Adurometer hardness material) and with 0.055, 0.065, and 0.075 inch wallthickness respectively and Group D represents similar individualinjections into tubes made from an elastomeric silicone material havinga measured durometer hardness of 30 A before processing into the tubes(i.e., a 30 A durometer hardness material) with wall thickness of 0.045inches. As indicated in FIG. 1B: Group 1 represents the injection of 100ml into 5 individual tubes with 0.065 wall thickness and a 30 Adurometer hardness material; Groups 2, 3, and 4 represent similarindividual injections into tubes of 35 A durometer hardness material andrespective wall thickness of 0.045, 0.055 and 0.065 inches. For eachindividual injection (cycle, ˜15 second in duration) a maximum CrackPressure is the left-most peak and a maximum Fill Pressure is theright-most peak.

The Groups of FIG. 1A and FIG. 1B illustrate the variations observed forCrack and Fill Pressures for silicone tubes in general (of the inventionand not of the invention). Groups A-C (FIG. 1A) and Group 1 (FIG. 1B)exhibit maximum Crack Pressures that are less than the maximum FillPressures; Group 4 (FIG. 1B) exhibits the reverse; Groups D (FIG. 1A),Groups 2 and 3 (FIG. 1B) exhibit instances for such maximum pressuresbeing greater than, less than, or equal to one another. The informationdepicted in FIGS. 1A and 1B suggests that for tubes of the same innerdiameter (ID):

-   -   Silicone tubes of 30 A and less durometer hardness material        exhibit maximum Crack Pressures that are less than the maximum        Fill Pressures    -   For silicone tubes of a given durometer hardness, the thicker        the wall the greater the maximum Crack Pressure with respect to        the maximum Fill Pressure

More conclusive for tubes of a given ID are the following relationshipsamong Fill Pressures, wall thickness, and durometer hardness:

-   -   At a given wall thickness, the greater the durometer hardness        the greater the Fill Pressures    -   At a given durometer hardness, the thicker the walls the greater        the Fill Pressures

Thus there are numerous combinations for durometer hardness and wallthickness that one can choose to achieve a specific maximum FillPressure.

One method for recording Fill Pressures is to average the minimum andmaximum Fill Pressures into a single Average Fill Pressure value for agiven fill cycle. FIG. 2 illustrates such minimum and maximum datapoints for calculating an Average Fill Pressure (Ave Fill Pressure) fora mandrel supported silicone tube of the invention with the tube havinga 0.10″ wall thickness, an ID of 0.355 inches, and a length of 3.05inches. In FIG. 2, the y-axis represents the pressure of liquid in theinflatable tube and the x-axis is time in seconds. The cycle isapproximately 15 seconds in duration, starting at about 35 seconds andending at about 50 seconds. Table 1 gives such average values for thedata represented in FIG. 1 and for additional groups T and E (, notshown in the FIG. 1 but with 5 individual fill cycles each) as; theseAverage Fill Pressure values correspond to the “Unsterilized As-Made”sample type values in Table 1. Also presented in Table 1 is data forother samples that are the same as the Unsterilized As-Made but afterexposure to one of two types of sterilization: “Post-Gamma” values arefor samples after their sterilization by exposure to gamma radiation;“Post-EtO” values are for samples after their sterilization by exposureto ethylene oxide. As the values of Table 1 indicate, ethyene oxidesterilization has negliglbe effect while gamma radiation increases theCrack and Fill Pressures by ˜6 to ˜16%. Such impact due to sterilizationconditions is also observed for other silicone tubes of 30 A durometerhardness material with walls up to 0.180 inch thickness, and presumedlygreater.

TABLE 1 Average Fill Pressure (PSIG) Group T A B C D E 1 2 3 4Durometer - Wall thickness 25A- 25A- 25A- 25A- 30A- 30A- 30A- 35A- 35A-35A- .045 .055 .065 .075 .045 .055 .065 .045 .055 .065 Sample Type:Unsterilized As-Made 15 17 17.5 19 19 21 23 25 27 30 Post-Gamma 16 16 2022 21 24 25 28 30 34 Post-EtO 15 17 17 20 20 21 24 25 28 31

FIG. 2 shows that both the maximum Crack and Fill Pressures are lessthan 35 psig; this criteria, regardless of time duration for the fillcycle, is a desirbable characteristic of the invention.

While Crack and Fill Pressures reflect the pressure conditions that acton the silicone tubes, Operating Pressures directly provide informationabout the actual pressure conditions on the tubes. The OperatingPressures are measured downstream of the mandrel and silicone tubeinvention and have no intervening blockage in the liquid flow path fromthe silicone tube to the pressure sensor. Thus the pressure acting onthe silicone tube is transmitted hydrostatically and continuouslydownstream of the invention. Because the downstream conduits aregenerally designed to delivery approximate flow rates of 1-4 ml/hour,pressure conditions against the silicone tube equilibrate relativelyquickly with pressure conditions downstream of the mandrel and siliconetube assembly. When the pressure sensor is inserted into directcommunication with the liquid in the conduit (e.g. tubing) within 2 feetof the first port the measured pressures via the sensor are essentiallythose acting on the silicone tube; thus such Operating Pressures areportrayals of the actual pressures on the silicone tube.

Silicone tubes of interest for the invention share a commoncharacteristic “depressurization” profile as liquid, initially at a FillVolume, is squeezed out of the silicone tube and delivered downstreamover time. FIG. 3 provides an illustrative example of the characteristicdepressurization curve; the example is representative of the dimensionsof Tube 1 per Table 2 and of a silicone with a durometer hardness of 30A. In FIG. 3, the y-axis is average operating pressure of liquid in theinflatable tube and the x-axis is volume of liquid in the tube.

Additional exemplary dimensions for silicone tubes of the invention aregiven in Table 2. Each of the tubes have mandrels that support the tubein the absence of contained liquid; the respective mandrel (for Tubes 1,2, 3, 4) has an OD sized to match the ID of the tube and a lengthgreater than the tube.

TABLE 2 Tube Silicone Tube Dimensions, inches 1 2 3 4 ID, inch 0.355 0.60.6 0.6 OD, inch 0.555 0.88 0.88 0.96 Wall, inch 0.1 0.14 0.14 0.18Length, inch 3.05 3.75 4.75 4.75 Tube Volume, in³ 0.43597 1.220511.54598 1.65405 Fill Volume, ml (in³) 100 (6.1024) 250 (15.256) 400(24.409) 600 (36.6140)

Silicones with a durometer hardness (Shore hardness) of 35 A or less aresuitable for forming the tube. Such silicones in the dimensionsrepresented by Tubes 1-4 allow for allow expansion of the tube tocontain liquids up to the indicated Fill Volumes. Appropriate selectionof silicones are ones that: form inflatable tubes; result in any maximumpressures that are greater than 12 psig but less than 35 psig wheninflated with a predetermined Fill Volume of liquid as measured a shortdistance downtream of the first port; and provide sufficent constrictingforces to expell almost all the Fill Volume liquid. Exemplary siliconesare: NUSIL 4020 (also called MED-4020) with a Shore hardness of 25 A (asreported by the manufacturer); NUSIL 4025 (also called MED-4025) with aShore hardness of 30 A (as reported by the manufacturer); NUSIL 4030(also called MED-4035) with a Shore hardness of 35 A (as reported by themanufacturer). NUSIL 4025 is a preferred silicone. The durometerhardness of the silicone that is used to make the tubes is a materialparameter of the invention. Values for the durometer hardness aremeasured and given per the Shore A scale. The exemplary siliconepolymers sold under the designation NUSIL MED-4020, MED-4025 andMED-4035, as well as other polymers (e.g., MED-4050, MED-4065) areavailable from NuSil Technology, LLC of Carpinteria, Calif., USA.

The Shore Hardness testing of plastics is most commonly measured by theShore (Durometer) test using either the Shore A or Shore D scale. TheShore A scale is used for “softer” rubbers while the Shore D scale isused for “harder” ones. The Shore A Hardness is the relative hardness ofmaterials such as rubber or soft plastics and can be determined with anapparatus known as a Durometer and is sometimes also referred to asDurometer Hardness (or durometer hardness).

The hardness value is determined by the penetration of the Durometerindenter foot into the sample. If the indenter completely penetrates thesample, a reading of 0 is obtained, and if no penetration occurs, areading of 100 results. The reading is dimensionless. Because of theresilience of rubbers and plastics, the hardness reading may change overtime so the indentation time is sometimes reported along with thehardness number. The durometer hardeness values measured for the tubespresented in connection with this invention are determined per ASTMD2240 procedures and use a time interval of approximately 1 secondbetween initial indentor travel cessation and the recording of theindicated reading (as considered standard). The analogous ISO testmethod to this ASTM test number is ISO 868. The given values for thematerial durometer hardness values are vendor provided.

It is noted that processing of the silicone into an inflatable tube andcuring the tube may have an impact on the Shore Hardness. Sterilizationof the tube and inflation/deflation or mechanical working of thematerial for at least one cycle may also have an impact on the ShoreHardness. Table 3 reports the Shore A Hardness measured for a series ofinflatable tubes corresponding to Inflatable Tube #3 from Table 2(Inside Diameter=0.6 inch, Outside Diameter 0.88 inch, Wall Thickness0.14 inch, design volume 400 milliliters). These tubes were made byextruding NUSIL 4025 (Shore ardness of 30 A as reported by themanufacturer—also referred to as Shore A hardness of 30). Three (3)separate tubes were tested. The average results and correspondingstandard deviations in Table 3 are for the extruded & cured tube; tubesterilized utilizing a conventional Ethylene Oxide (EO) sterilizationcycle; and sterilized tube loaded with sterile water and allowed todeflate over a period of approximately 279 hours (i.e., cycled). Theresults are based on six (6) measurements per tube.

TABLE 3 SHORE A HARDNESS Standard SAMPLE Average: n = 6 DeviationExtruded & Cured 37.00 1.14 EO Sterilized 36.83 2.70 EO Sterilized &Cycled 36.75 1.37

As can be seen from Table 3, extruding the Nusil 4025 into inflatabletubes and curing the tubes with heat increases the Shore A hardess froma nominal value of 30 (as reported by the manufacturer) for theunprocessed material to a value of about 37 for the tube. Sterilizationwith ethylene oxide and recoverable stretching do not appear to producea meaningful change to the Shore A hardness.

A structural parameter of the invention is the wall thickness, t, of theinflatable tube. An exemplary range of wall thicknesses for siliconetubes made from NUSIL 4025 are greater than 0.075 inches up to 0.180inches. Another structural parameter is the inner diameter, ID, of thetube and exemplary ranges are 0.355 inches to 0.600 inches. Anotherparameter is the length, L, of the tube. The Tube Volume (equivalentlyTube Vol and vtube) is derived from these parameters according toconventionally accepted mathematical relationships. Also from the t, ID,L, and Tube Vol values are certain ratios that can characterize theinvention.

Appropriate combinations of the structural and material parameters yieldtubes of the invention that accommodate Fill Volumes from 50-600 ml ofliquid.

FIG. 4 shows averaged Operating Pressure profiles for expanded tubesthat track their depressurization of liquid expelled from the expandedtube beginning from their Fill Volumes with respect to time (InfusionTime) reported in hours. The tubes used in making FIG. 4 are examples ofthe invention, have the structural parameters of Table 2, and are madefrom NUSIL 4025 silicone which has a material parameter of 30 Adurometer hardness. Table 4 identifies these examples as Examples 1-4and their respective connection to Table 2. Table 4 also specifies theOperating Pressure at ˜0 Infusion Time, which is essentially theequilibrated pressure that acts against the tube wall while containingall the Fill Volume. Additional information in Table 4 provides theDesign Flow rates that indicate the degree of downstream restrictionsthat are intentionally made to modulate the flow rate and specifies thenumber of individual samples for the examples that were used to obtainthe averaged Operating Pressure profiles.

Each profile of FIG. 4 displays the depressurization charactertistics ofFIG. 3: a maximum Operating Pressure at 0 Infusion time, a second peaktowards the completion of depressurization, and a generalized plateaubetween the maximum Operating and second peak pressures. The pressurevalues for Ex. 1 are similar to those for the tube of FIG. 3 (Tube 1) asexpected since they have structural and material parameters in common.FIG. 4 shows pressures with respect to time while FIG. 3 shows them withrespect to expelled volume (volume in the tube and infusion time areinterrelated). It is noteworthy that the second peaks and plateaus ofeach profile have similar pressure values. As shown subsequently, thedifferences in the maximum Operating Pressures can be explained viaratios that are based on certain structural parameters.

FIG. 4 also indicates that almost all of the Fill Volume liquid isexpelled at the completion of depressurization. This is an importantfeature of the invention. Desirably, none of the tubes of the inventionretain more than just a few millileters of liquid upon completedepressurization. For example, the tubes of the present invention retainless than about 10 mls of liquid upon complete depressurization. Asanother example, the tubes of the present invention retain less thanabout 5 mls of liquid upon complete depressurization. As yet anotherexample, the tubes of the present invention retain less than about 4 mlsof liquid upon complete depressurization. As still another example, thetubes of the present invention retain less than about 2.5 mls of liquidupon complete depressurization.

TABLE 4 Structural Parameters that correspond Design Fill Operating ~0Calculated to Table 2 Flow rate, Volume, Pressure, Infusion Expel Ex.Silicone Tube Description per FIG. 4 ml/hr ml psig time, hrs Time, hr 11 0.100″ (100 mlx2, n = 19)  2 100 13.14 0 50 2 2 140″ (270 mlx1, n =20) 1 270 12.58 0.5 270 3 3 140″ (400 mlx4, n = 20) 4 400 11.24 0.083100 4 4 180″ (600 mlx2, n = 3)  2 600 13.09 0 300

For purposes of characterizing tubes that are not representative of theinvention, it has been found that tubes made from NUSIL 4025 (materialdurometer hardness=30 A) with wall thickness of 0.075 or less lacksufficent constrictng forces in the expanded tube to expel almost all ofthe Fill Volume at the desired Operating Pressures. The importance ofhaving sufficent constricting force to expel the Fill Volume liquid isshown in FIG. 5. More particularly, FIG. 5 is a graph of OperatingPressure of liquid expelled from the tube (that is measured downstreamfrom the silicone tube and support mandrel and before flow restrictors)for four different sample sets of silicone tubes versus infusion time(reported in hours). All the tubes were made from NUSIL 4025 (Shorehardness 30 A) with a length of 3.05 inches and an ID of 0.355 inchesand were filled with a Fill Volume liquid of 100 ml.

The top curve of FIG. 5 represents Ex. 1, a tube with 0.100″ thick walland indicates acceptable pressure behavior with respect to theinvention; the next highest curve represents Ex. C, a tube with 0.075″thick wall; the following curve represents Ex. B, a tube with 0.065″thick wall; and the lowest curve represents Ex. A, a tube with 0.055″thick wall. After 50 hours, only the tube with 0.100″ thick wallexpelled all of the Fill Volume liquid; the other tubes had insufficentconstricting forces to overcome the downstream restrictions thatdramatically slowed expulsion of the 100 ml Fill Volume from thosetubes. FIG. 5 also provides a comparison of the maximum OperatingPressures that expand the tube walls away from the mandrel when thetubes contain all 100 ml of the Fill Volume liquid; these pressures arethe “Y” intercepts of the curves at 0 Infusion time. (At 0 Infusiontime, when none of the Fill Volume has been expelled, the OperatingPressure essentially equals the expanding pressure that provides theforce to counter the constricting forces that are inherent in the tube.)These expanding pressures for 100 ml Fill Volume liquid are given inTable 5.

TABLE 5 0.355″ ID × 3.05″ length tubes from NUSIL 4025 silicone (Shorehardness of 30A - as reported by manufacturer) supported on matchingmandrels Example Ex. A Ex. B Ex. C Ex. 1 Tube Wall, inch 0.055 0.0650.075 0.100 Expanding pressure, psig 4.434 5.0875 5.874 13.138 (at 0Infusion time)

To further establish the direct connection between Operating Pressuresand pressures acting against the tubes the following ‘static’ experimentwas conducted. The pressures at a very short distance downstream of thefirst port were recorded as selected mandrel-supported silicone tubes,suitable for the invention, were inflated to and deflated from FillVolumes in 25 ml increments. The selected tubes are identified as Ex.11, 21, 31, and 41 and are described with respect to structuralparameters in Table 6. These tubes were made from NUSIL 4025, thus theirmaterial parameter was a durometer hardness of 30 A. That is, the tubeswere made from a material having a durometer hardness of 30 A prior toprocessing into the tubes. Table 6 also reproduces the recordedpressures (pressure data points) for each Ex. 11, 21, 31, and 41 withrespective Fill Volumes of 100, 250, 400, and 600 milliliters asobtained via the following ‘Inflation/Deflation Curves’ Procedure. Thesepressures were graphed in FIG. 6 with respect to volume to give aninflation curve towards each respective Fill Volume and a deflationcurve away from the Fill Volume. (The pressure data points for injectingare shown as solid markers; those of dispensing are unfilled markers.)

Inflation/Deflation Curves Procedure for Ex. 11, 21, 31, and 41 (theStatic Experiment):

1. Obtain a new mandrel and silicone tube assembly with attacheddownstream conduit

2. Cut the downstream conduit approximately 5″ from its connection endto the mandrel and attach male Luer with two connection ports, one witha valve mechanism that is closed.

3. Connect the pressure transducer to the connection port without thevalve mechanism and prime the line with saline before connection.

4. Using a syringe, inject 25 ml of saline for each pressure data pointthrough the valve mechanism when opened.

5. Measure pressure one minute after each injection.

6. Repeat until Fill Volume is obtained.

7. Measure pressure as the silicone tube is depressurized (emptied)dispense 25 ml at a time by opening the valve mechanism. Measurepressure one minute after 25 ml is dispensed until all of the FillVolume is removed.

TABLE 6 Pressure, PSI for: Reservoir Tube Ex. 11 Ex. 21 Ex. 31 Ex. 41Tube Exterior 0.555″ OD × 0.880″ OD × 0.880″ OD × 0.960″ OD × Dimensions3.05″ L 3.75″ L 4.25″ L 4.25″ L Wall thickness 0.10″ 0.14″ 0.14″ 0.18″to Fill from Fill to Fill from Fill to Fill from Fill to Fill from FillVol, ml Vol Vol Vol Vol Vol Vol Vol Vol 0 0 0 0 0 0 0 0 0 25 13.39 7.9914.71 8.29 14.43 7.36 18.53 7.78 50 14.46 8.21 14.5 7.93 14.41 7.5 18.838.65 75 16.31 10.17 14.09 7.81 13.32 7.07 17.74 8.37 100 18.11 18.1114.1 7.73 13 6.95 16.95 7.92 125 14.23 7.98 12.91 6.95 16.58 7.68 15014.49 8.37 12.86 6.9 16.4 7.49 175 14.81 8.75 12.36 6.96 16.28 7.6 20015.12 9.72 12.67 7.01 16.25 7.61 225 15.35 11.1 12.87 7.31 16.31 7.69250 15.59 15.59 13.1 7.73 16.41 7.61 275 13.32 8.08 16.5 7.79 300 13.538.64 16.53 8 325 13.77 9.33 16.42 8.18 350 14.01 9.98 16.39 8.1 37514.27 11.16 16.43 8.42 400 14.54 14.54 16.54 8.69 425 16.66 9.15 45016.81 9.43 475 17.01 10.28 500 17.24 10.84 525 17.5 11.81 550 17.7512.65 575 18.01 13.97 600 18.3 18.3

The inflation curves of FIG. 6 share characteristics of the Crack andFill Pressures previously described and the deflation curves closelymirror the Operating Pressures for tubes of similar structural andmaterial parameters and relatively similar Fill Volumes. Table 7compares maximum, second peak and general plateau pressures as shown inFIG. 6 per Table 6 with maximum, second peak, and general plateauOperating Pressures as given in previous Tables and Figures.

The magnitudes of the pressures at the Fill Volumes of FIG. 6 alsoindicate a relationship between pressure and actual wall thickness. Ex.11 with the thinnest initial wall and shortest for length, thus it hasthe smallest Tube Volume (per Table 8, equivalent to dimensions of Tube1 per Table 2), has a pressure at its Fill Volume (100 ml) that iscomparable to that for Ex. 41 (at 600 ml Fill Volume), which has thethickest initial wall and longest length, hence the greatest Tube Volume(per Table 8, equivalent to dimensions of Tube 4 per Table 2). Ex. 21and Ex. 31 have lower pressures at their Fill Volumes.

One explanation for the magnitude differences in pressures at respectiveFill Volumes is that: Ex. 11 and Ex. 41 should have comparably thinneractual walls at their Fill Volumes compared to Ex. 21 and Ex. 31 andtherefore exert the greater constricting forces per unit surface area atthese Fill Volume; Ex. 21 should have the next thinner actual wall atits Fill Volume and thus the next greater constricting force per unitarea; Ex. 31 should have an actual wall thickness at its Fill Volumethat is greater than that of Ex. 21 and therefore has less constrictingforce per unit surface area. In other words Ex. 11 and Ex. 41 areexpanded (stretched) more towards their limit of plastic deformation(yield point, past which the tube will not quickly return to itsoriginal dimensions before filling). Ex. 21 and 31 should berespectively thicker and thus should allow for more expansion beforereaching the actual thinness of Ex. 11 at its Fill Volume. The OperatingPressures of Ex. 1-4 per Table 7 show similar magnitude differences thatare consistent with the offered explanation: the maximum pressure of Ex.1 (like Ex. 11) is comparable to Ex. 4 (like Ex. 41) while the maximumpressures for Ex. 2 (like Ex. 21) and Ex. 3 (like Ex. 31) are less.

The offered explanation is further supported when the shape of each tubeat its Fill Volume is assumed to be a sphere and tube is assumed to forma shell around the sphere. Given the accepted volume-to-radiusrelationship for a sphere, the above assumptions, and the appropriatevalues of Table 8, the shell thicknesses at each Fill Volume calculateas: 0.0264″ for Ex. 11, 0.0306″ for Ex. 41; 0.0399″ for Ex. 21; 0.0372″for Ex. 31.

Table 7 also gives maximum pressure values (all Operating Pressures) forexamples Ex. A, B, and C, which are lower than Ex. 1, and thus incontradiction to the preceding explanation. This contradiction can beexplained if the initial Crack and Fill Pressures for Ex. A, B, and Ctubes produced stretching forces that closely approached or exceeded thelimit of plastic deformation so that these tubes will not recover theirinitial dimensions. The lack of respective second peaks in pressure perFIG. 5 indicates this is the case.

Table 7 allows comparisons of the maximum pressures at Fill Volumes(Fill) for tubes that are essentially the same: values for Ex. 11 tothose of Ex. 1; those of Ex. 21 to those of Ex. 2; etc. The differencein the maximum pressures at Fill can be explained as stress relaxationphenomena common to elastomeric materials. The measured pressures atFill for Ex. 11-Ex. 41 were all made 1 minute after the Fill volume wasattained. The maximum pressures for Ex. 1-4 are the Operating Pressuresat 0 infusion time, which implies these examples have been containingthe same respective Fill Volumes as for Ex. 11-Ex. 41 for sufficientlylong enough periods of time to allow some of the molecular entanglementsthat are initially present when the tubes are inflated to rearrange anddissipate some of the constricting energy. Indeed, should the maximumpressure for Ex. 11 have been held for a time longer than that given perthe procedure, it is conceivable that the maximum pressure value for Ex.11 will decay to the lower maximum pressure value for Ex. 1. In otherwords, the maximum pressures at Fill per the Inflation/Deflation Curvesprocedure should decay to the equilibrium pressures as represented bythe Operating pressures at) infusion time.

TABLE 7 Pressure values Wall × Maximum Second Tube Source Length, inchat Fill Peak Plateau Ex. 11 Table 6 0.010 × 3.05 18.11 7.99 7.99-8.21Ex. 1 FIG. 4 data; 13.14 7.94 7.94-9.01 FIG. 3 Ex. 21 Table 6 0.140 ×3.75 15.59 8.29 8.29-9.72 Ex. 2 FIG. 4 Data 12.56 7.50 7.50-8.35 Ex. 31Table 6 0.140 × 4.75 14.54 7.50 7.50-9.33 Ex. 3 FIG. 4 data 11.24 7.467.46-8.50 Ex. 41 Table 6 18.3 8.65 8.65-9.43 Ex. 4 FIG. 4 data 0.180 ×4.75 13.09 6.81 6.81-7.02 Ex. A Table 2; 0.055 × 3.05 4.43 — 2.80-3.00FIG. 5 Ex. B Table 2; 0.065 × 3.05 5.09 — 2.90-3.50 FIG. 5 Ex. C Table2; 0.075 × 3.05 5.87 — 3.80-4.20 FIG. 5

When ratios based on structural parameters for the tubes of Table 6 arecompared in light of their pressure values, these ratios point to rangesthat characterize the suitability for use in the invention. Table 8lists structural parameters and various ratios based on them. Of primaryrelevance for defining dimensions for tubes that may be suitablecandidates for use in the invention are the ratios of wall thickness tto tube inner radius r or the outer radius as shown in items j) and k)respectively. Since these ratios are expressions of the same structuralparameters, item j), the ratio of t to the inner tube radius r, will beused to identify limitations. Of secondary relevance is the ratio forthe Fill Volume to the Tube Volume, as shown in item I). Given thattubes of Ex. 1-4 and Ex. 11-41 (all from 30 A durometer hardnessmaterial) exhibit preferred pressure behavior up to their respectiveFill Volumes, their ratio values per item j) and item I) are within therange of acceptability for the invention. Since Ex. C exhibitsunacceptable pressure behavior at its indicated Fill Volume, the valueof the j) ratio lies outside the lower limit of acceptability. The valueof the item j) ratio for Ex. 4 & Ex. 41 is determined to be within theacceptable range per its pressure behavior up to its Fill Volume andsets an upper limit in light of the value for the ratio of item I)versus those for Ex. A and Ex. B, which have unacceptable pressurebehaviors for their Fill Volumes. In other words, acceptable structuralparameters for tubes suitable for the invention are defined by item j)ratios from greater than 0.42254 to 0.6.

A graphic depiction of such an acceptable range is illustrated by FIG. 8which is derived from Fill values of FIG. 7 that are based on Table 7data points for maximum at Fill values that correspond to Operatingpressures at 0 infusion time. FIG. 7 shows the same information as FIG.6 but includes the maximum pressures per Table 7 for Ex. A-C(unacceptable for the invention) and Ex. 1-4 (acceptable for theinvention). FIG. 8 plots the maximum pressures per Table 7 for Ex. A-Cand Ex. 1-4 with respect to their corresponding wall thickness; clearlya lower bound of acceptability for tubes with ID values of 0.355 inchesexists for wall thickness between 0.075 and 0.100 inches and an upperbound seemingly exists for tubes of ID values of 0.600 inches and a wallthickness of or near 0.180 inches.

TABLE 8 Examples Ex. 1 & Ex. 2 & Ex. 3 & Ex. 4 & item Ex. A Ex. B Ex. CEx. 11 Ex. 21 Ex. 31 Ex. 41 a) ID, in 0.355 0.355 0.355 0.355 0.6 0.60.6 b) OD, in 0.465 0.485 0.505 0.555 0.88 0.88 0.96 c) t (Wall), in0.055 0.065 0.075 0.1 0.14 0.14 0.18 d) L (Length), in 3.05 3.05 3.053.05 3.75 4.75 4.75 e) Tube Vol, in³ 0.21607 0.26158 0.30901 0.435971.22051 1.54598 1.65405 f) Fill Vol, in³ 6.1024 6.1024 6.1024 6.102415.256 24.409 36.614 g) Fill Vol, ml 100 100 100 100 250 400 600 h) r(=ID/2), in 0.1775 0.1775 0.1775 0.1775 0.3 0.3 0.3 i) R (=OD/2), in0.2772 0.2772 0.2772 0.2772 0.44 0.44 0.48 j) t/r 0.30986 0.366200.42254 0.56338 0.46667 0.46667 0.6 k) t/R 0.23656 0.26804 0.297030.36036 0.31818 0.31818 0.375 l) Fill Vol/ 28.2427 23.3290 19.748213.9973 12.4997 15.7887 22.1360 Tube Vol

The relationship of the pressures at the Fill Volumes per theInflation/Deflation Curves Procedure to the Operating Pressures wasdemonstrated by duplicating the filling part of the Procedure to theFill Volume with a new (previously unexpanded) set of Ex. 11, 21, 31,and 41 tubes, which are identified as Ex. 11A, 21A, 31A, and 41A, andthen modifying the Procedure to allow 24 hours to lapse. Once thepressures were recorded approximately 1 minute after reaching their FillVolume, the tubes retained these Fill Volumes for approximately 24hours, then the pressures at the Fill Volume were recorded again and theemptying part of the Procedure was subsequently followed. As the resultsgiven in Table 9 show, all the after 24 hours Fill Volume pressures werelower than the after 1 minute Fill Volume pressures by 30-34%. ComparingTable 9 to Table 6 values indicates that the 24 hour delay also resultsin lower pressures as liquid is removed.

TABLE 9 Pressure, PSI for: Reservoir Tube Ex. 11A Ex. 21A Ex. 31A Ex.41A Tube Exterior 0.555″ OD × 0.880″ OD × 0.880″ OD × 0.960″ OD ×Dimensions 3.05″ L 3.75″ L 4.25″ L 4.25″ L Wall thickness 0.10″ 0.14″0.14″ 0.18″ to Fill After to Fill After to Fill After to Fill After Vol,ml Vol 24 hrs Vol 24 hrs Vol 24 hrs Vol 24 hrs 0 0 0 0 0 0 0 0 0 2513.61 7.56 14.60 6.33 15.86 5.06 18.21 6.06 50 13.3 6.98 14.72 6.9114.76 6.27 18.45 8.14 75 15.28 7.35 14.37 6.50 13.81 6.09 17.34 8.14 10017.14 12.01 13.83 6.38 13.38 5.94 16.53 7.86 125 13.86 6.66 13.10 5.7516.06 7.54 150 14.09 6.91 12.86 5.82 15.75 7.20 175 14.54 6.94 12.685.99 15.47 7.19 200 14.93 7.37 12.57 5.88 15.41 7.21 225 15.32 8.3012.62 5.86 15.34 7.18 250 15.84 10.71 12.76 6.02 15.20 7.40 275 12.926.27 15.34 7.23 300 13.01 6.48 15.47 7.51 325 13.09 6.71 15.66 7.40 35013.28 7.34 15.87 7.50 375 13.57 8.51 15.35 7.64 400 13.90 9.36 15.757.86 425 16.05 8.10 450 16.32 8.64 475 16.61 8.90 500 16.89 9.57 52517.14 9.99 550 17.41 10.76 575 17.66 11.81 600 17.90 12.36

Comparison of the Operating Pressures of Table 4 to the after 24 hourFill Volume pressures of Table 9 for tubes of like structural parametersleads to the conclusion that these pressures are essentially the same. Afactor that may account for the slightly higher Operating Pressurevalues of the Examples of Table 4 compared to the after 24 hour FillVolume pressures of Table 9, in addition to possible inherent variationsof the individual samples themselves, was the presence of a confiningnon-stretchable housing as described in U.S. Pat. No. 5,284,481 aroundthe tubes for Table 4 examples, while the tubes of Table 9 lacked such ahousing. Such a confining housing was also present for all the examplesand samples used for Table 1, 3, and 5, while the examples of Table 6,9, and 10 lacked a confining housing around the tubes.

The Inflation/Deflation Curves Procedure was also used to see ifoverfilling of the reservoirs would cause insufficient constrictingforces in the expanded tube to expel the final amounts of liquid. Anunexpanded tube Ex. 11B with structural parameters like those of Ex. 1,11 and 11 A was filled to a Fill Volume of 200 ml according to theInflation/Deflation Curves Procedure used to generate the values ofTable 9 (with a 24 hour delay after reaching the Fill volume). Theresults are given in Table 10 and show that, for this tube, thestructural parameters are adequate to provide sufficient constrictingforces to expel all the filled liquid. Comparing the “to Fill Vol”values up to 100 mls for this Ex. 11 B to those of Ex. 11 A (Table 9)and Ex. 11 (Table 6) shows there is a range in measured pressures thatis most likely due to sample variability (all these tubes have the samestructural parameters): 12.09 psig for Ex. 11 B, 17.14 psig for Ex. 11A,and 18.11 psig for Ex. 11. The ratio of Fill Volume of 200 ml/Tube Volis approximately 28.

TABLE 10 Pressure, PSI for: Reservoir Tube Ex. 11B Tube Exterior 0.555″OD × Dimensions 3.05″ L Wall thickness 0.10″ Vol, ml to Fill Vol After24 hrs 0 0 0 25 12.53 6.56 50 11.92 5.25 75 11.79 5.03 100 12.09 5.35125 12.77 6.28 150 13.41 7.13 175 14.00 8.33 200 14.53 —

Comparative examples that further support the unique criteria of theinvention are found from U.S. Pat. No. 7,704,230; such comparativeexamples use reservoirs made of silicone that match the materialparameters of the invention, yet their structural parameters aredifferent from those found to be acceptable for the invention. WithinU.S. Pat. No. 7,704,230 are descriptions of certain silicone reservoirsmade of NUSIL 4025 that are understood to have cylindrical tube shapesthat “hold about 300 milliliters”. These reservoirs are stated to havethe following dimensions: Comp. Ex. 1 has “a preferred axial length ofabout 3.5 inches, a preferred outer diameter of about 0.130 inches and apreferred inner diameter of about 0.080 inches”; Comp. Ex. 2 and Comp.Ex. 3 each “preferably has a wall with a thickness of about 0.063inches” and is presumed to have the same axial length and either theinner or the outer diameter of Comp. Ex. 1. Calculations for structuralparameters and ratios like those of Table 8 are made for thesecomparative examples based on these stated dimensions; these are listedin Table 11. An additional comparative example, Comp. Ex. 4, is givenwith an axial length of 3.5 inches and an inner diameter of 0.080 inchesbut with a wall thickness of 0.0315 inches (half of 0.063 inches).

TABLE 11 Examples: Comp. Comp. Comp. Comp. item Ex. 1 Ex. 2 Ex. 3 Ex. 4a) ID, in 0.080 0.080 0.004 0.08 b) OD, in 0.130 0.206 0.130 0.143 c) t(Wall), in 0.025 0.063 0.063 0.0315 d) L (Length), in 3.50 3.50 3.503.50 e) Tube Vol, in³ 0.115 0.396 0.186 0.154 f) Fill Vol, in³ 18.3118.31 18.31 18.31 g) Fill Vol, ml 300 300 300 300 h) r (=ID/2), in 0.0400.040 0.002 0.040 i) R (=OD/2), in 0.0625 0.103 0.0625 0.0715 j) t/r0.625 1.575 31.5 1.575 k) t/R 0.400 0.612 1.008 0.881 l) Fill Vol/159.217 46.185 98.573 118.464 Tube Vol

Referring again to FIGS. 6 and 7, it appears the tubes generally followHooke's law between zero pressure and a yield point above the designedoperating pressure for the infusion pump (i.e., 6 psi). This Hooke's lawbehavior is observed for both the inflation profile and the deflationcycle profile. For the present invention, the more important yield pointis a “deflation yield point” that appears at about 7 to 8 psi in thedeflation portion of the inflation/deflation cycle for all sizes of theinfusion pumps (i.e., 100 ml to 400 ml).

With reference to FIGS. 6 and 7 as well as Table 6, the plot of pressureversus volume during inflation of “Ex.11 to fill” illustrates thatpressure of fluid in the inflatable elastomeric tube increases in asubstantially linear manner from zero to an inflation yield point (atabout 13.4 psig) that is above the target operating pressure (about 6psig) as the volume increases from 0 milliliters to a volume of about 25milliliters. As another example, the plot of pressure versus volumeduring inflation of “Ex. 41 to fill” illustrates that pressure of fluidin the elastomeric tube increases in a substantially linear manner fromzero to an inflation yield point (at about 18.5 psig) that is above thetarget pressure (about 6 psig) as the volume increases from 0milliliters to a volume of about 25 milliliters.

Once the pressure exceeds the inflation yield point, the pressure-volumerelationship is generally non-linear. That is, as the volume of thefluid in the inflatable elastomeric tube increases, the pressure of thefluid in the inflatable elastomeric tube has a less predictable responseand will increase or decrease with changes in volume changes. Thisresponse is non-Hookean (i.e., does not follow Hooke's law) and isattributed to stretching and deformation of the inflatable tube. As canbe seen from FIGS. 6 and 7, the plot of pressure versus volume duringinflation of “Ex.11 to fill” illustrates that pressure of fluid in theinflatable elastomeric tube increases in a generally non-linear mannerfrom the inflation yield point (at about 13.4 psig) to the end of theinflation cycle as the volume increases from about 24 milliliters to avolume of about 100 milliliters. As another example, the plot ofpressure versus volume during inflation of “Ex. 41 to fill” illustratesthat pressure of fluid in the elastomeric tube responds in a generallynon-linear manner from the inflation yield point (at about 18.5 psig) tothe end of the inflation cycle as the volume increases from about 15milliliters to a volume of about 600 milliliters.

During deflation of the inflatable elastomeric tube, the pressure-volumerelationship is generally non-linear until the pressure decreases belowa deflation yield point. For example, the plot of pressure versus volumeduring deflation of “Ex.11 from fill” illustrates that pressure of fluidin the inflatable elastomeric tube decreases in a generally non-linearmanner from the end of the inflation cycle/beginning of the deflationcycle to the deflation yield point (at about 8 psig) as the volumedecreases from about 100 milliliters to a volume of about 25milliliters. As another example, the plot of pressure versus volumeduring deflation of “Ex. 41 from fill” illustrates that pressure offluid in the elastomeric tube responds in a generally non-linear mannerfrom the end of the inflation cycle/beginning of the deflation cycle tothe deflation yield point (at about 7.8 psig) as the volume decreasesfrom about 600 milliliters to a volume of about 25 milliliters.

Referring to “Ex. 11 from fill” and to “Ex. 41 from fill”, as thepressure decreases below the deflation yield point, the pressure andvolume decrease in a substantially linear relationship until the volumedecreases to 0 ml. It is believed that providing a deflation yield pointthat is above the target operating pressure of the infusion pump allowsfor the reliable and generally complete evacuation or depletion of thecontents of the infusion pump.

Accordingly, the improved elastomeric pump can be described as aninfusion pump providing a modified hysteresis profile with a deflationyield point that is above the target operating pressure of the pump. Theadditional thickness (>0.100″) and choice of material (NuSil 4025A) inthe inflatable tube provides an extended range of Hooke's law responsewhich is important in providing a uniform flow rate—particularly at lowvolumes associated with depletion of the pump contents. Normally, thesilicone elastomer (even NuSil 4025A) is non-Hookean as elasticity isstress dependent which can readily be seen in the other portions of theinflation-deflation profile.

While various patents have been incorporated herein by reference, to theextent there is any inconsistency between incorporated material and thatof the written specification, the written specification shall control.In addition, while the disclosure has been described in detail withrespect to specific embodiments thereof, it will be apparent to thoseskilled in the art that various alterations, modifications and otherchanges may be made to the disclosure without departing from the spiritand scope of the present disclosure. It is therefore intended that theclaims cover all such modifications, alterations and other changesencompassed by the appended claims.

What is claimed is:
 1. An elastomeric pump for an infusion assembly, thepump comprising: a mandrel comprising a body having a first end and anopposed second end, a length, a central bore extending through thelength, a first port positioned between the first end and second end andin fluid communication with the bore to provide a fluid passageway, afill port in fluid communication with the bore, and an exit port influid communication with the bore; and an inflatable elastomeric tubedisposed concentrically about the mandrel, the tube positioned betweenthe first end and second end of the mandrel and covering the first port,the tube being sealingly secured on the mandrel near the respective endsof the tube and having an original inner diameter that corresponds to aradius (r), a length (L) less than the length of the mandrel, and a wallthickness (t) such that:(0.4225×r)<t≦(0.660×r).
 2. The pump of claim 1, wherein the mandrelcomprises a radius (R_(mandrel)) and a generally uniform outer diameterthat matches the original inner diameter of the inflatable tube.
 3. Thepump of claim 1, wherein the inflatable tube further comprises a volume(v_(tube)) of an elastomeric material:v _(tube) =πL(2rt+t ²).
 4. The pump of claim 1, wherein the introductionof a volume of liquid (v_(liquid)) determined according to the followingequation:(12.50×v _(tube))≦v _(liquid)≦(22.16×v _(tube)) through the fill port ata fill pressure of greater than 0 and less than 35 psig expands theinflatable elastomeric tube between the mandrel and the elastomeric tubesuch that the pump subsequently dispenses the volume of liquid throughthe first port upon contraction of the tube to its original innerdiameter.
 5. The pump of claim 1, wherein the elastomeric material is anelastomeric silicone.
 6. The pump of claim 5, wherein the elastomericsilicone has a Shore Hardness of from 25 A to 40 A.
 7. The pump of claim1, wherein the inflatable tube is made from an elastomeric silicone suchthat the inflatable tube has a Shore Hardness of 37 A.
 8. An elastomericpump for an infusion assembly, the pump comprising: a mandrel comprisinga body having a first end and an opposed second end, a length, a centralbore extending through the length, a first port positioned between thefirst end and second end and in fluid communication with the bore toprovide a fluid passageway, a fill port in fluid communication with thebore, and an exit port in fluid communication with the bore; and aninflatable elastomeric tube disposed concentrically about the mandrel,the tube positioned between the first end and second end of the mandreland covering the first port, the tube being sealingly secured on themandrel near the respective ends of the tube and having an originalinner diameter that corresponds to a radius (r), a length (L) less thanthe length of the mandrel, and a wall thickness (t) such that:(0.4225×r)<t≦(0.660×r) the inflatable tube further comprising a volume(v_(tube)) of an elastomeric material:v _(tube) =πL(2rt+t ²) such that introduction of a volume of liquid(v_(liquid)) determined according to the following equation:(12.50×v _(tube))≦v _(liquid)≦(22.16×v _(tube)) through the fill port ata fill pressure of greater than 0 and less than 35 psig expands theinflatable elastomeric tube between the mandrel and the elastomeric tubesuch that the pump subsequently dispenses the volume of liquid throughthe first port upon contraction of the tube to its original innerdiameter.
 9. The pump of claim 8, wherein the mandrel comprises a radius(R_(mandrel)) and a generally uniform outer diameter that matches theoriginal inner diameter of the inflatable tube.
 10. An elastomeric pumpfor an infusion assembly, the pump comprising: a mandrel comprising abody having a first end and an opposed second end, a length, a centralbore extending through the length, a first port positioned between thefirst end and second end and in fluid communication with the bore toprovide a fluid passageway, a fill port in fluid communication with thebore, and an exit port in fluid communication with the bore; and aninflatable elastomeric tube disposed concentrically about the mandrel,the tube positioned between the first end and second end of the mandreland covering the first port, the tube being sealingly secured on themandrel near the respective ends of the tube and having an originalinner diameter that corresponds to a radius (r), a length (L) less thanthe length of the mandrel, and a wall thickness (t) such that:(0.4225×r)<t≦(0.660×r) and wherein the pump, upon inflation with apredetermined volume of liquid and during delivery of that liquid,exhibits a linear pressure versus volume curve from a deflation yieldpoint that is above a predetermined operating pressure to a volume thecorresponds with the dispensing of the volume of liquid through thefirst port upon contraction of the tube to its original inner diameter.11. The pump of claim 10, wherein the inflatable tube further comprisesa volume (v_(tube)) of an elastomeric material:v _(tube) =πL(2rt+t ²).
 12. The pump of claim 10, wherein theintroduction of a volume of liquid (v_(liquid)) determined according tothe following equation:(12.50×v _(tube))≦v _(liquid)≦(22.16×v _(tube)) through the fill port ata fill pressure of greater than 0 and less than 35 psig expands theinflatable elastomeric tube between the mandrel and the elastomerictube.
 13. The pump of claim 10, wherein the elastomeric material is anelastomeric silicone.
 14. The pump of claim 13, wherein the elastomericsilicone has a Shore Hardness of from 25 A to 40 A.
 15. The pump ofclaim 14, wherein the elastomeric silicone has a Shore Hardness of from35 A to 40 A.
 16. The pump of claim 15, wherein the inflatable tube ismade from an elastomeric silicone such that the inflatable tube has aShore Hardness of 37 A.
 17. An elastomeric pump for an infusionassembly, the pump comprising: a mandrel comprising a body having afirst end and an opposed second end, a length, a central bore extendingthrough the length, a first port positioned between the first end andsecond end and in fluid communication with the bore to provide a fluidpassageway, a fill port in fluid communication with the bore, an exitport in fluid communication with the bore; an inflatable elastomerictube disposed concentrically about the mandrel, the tube positionedbetween the first end and second end of the mandrel and covering thefirst port, the tube being sealingly secured on the mandrel near therespective ends of the tube and having an original inner diameter with aradius (r), a length (L) less than the length of the mandrel, a wallthickness (t) such that:(0.4225×r)<t≦(0.660×r) and; wherein the elastomeric material is anelastomeric silicone with a Shore Hardness of from 25 A to 40 A.
 18. Thepump of claim 17, wherein the inflatable tube further comprises a volume(v_(tube)) of an elastomeric material:v _(tube) =πL(2rt+t ²).
 19. The pump of claim 17, wherein theintroduction of a volume of liquid (v_(liquid)) is determined accordingto the following equation:(12.50×v _(tube))≦v _(liquid)≦(22.16×v _(tube)) through the fill port ata fill pressure of greater than 0 and less than 35 psig expands theinflatable elastomeric tube between the mandrel and the elastomeric tubesuch that the pump subsequently dispenses the volume of liquid throughthe first port upon contraction of the tube to its original innerdiameter.
 20. The pump of claim 17, wherein the elastomeric siliconesuch has a Shore Hardness of 37 A.
 21. The pump of claim 17, wherein theinflatable tube further comprises a volume (v_(tube)) of the elastomericmaterial:v _(tube) =πL(2rt+t ²) such that introduction of a volume of liquid(v_(liquid)) determined according to the following equation:(12.50×v _(tube))≦v _(liquid)≦(22.16×v _(tube)) through the fill port ata fill pressure of greater than 0 and less than 35 psig expands theinflatable elastomeric tube between the mandrel and the elastomeric tubesuch that the pump subsequently dispenses the volume of liquid throughthe first port upon contraction of the tube to its original innerdiameter.
 22. The pump of claim 17, wherein upon inflation with apredetermined volume of liquid and during delivery of that liquid, thepump exhibits a linear pressure versus volume curve from a deflationyield point that is above a predetermined operating pressure to a volumethe corresponds with the dispensing of all the volume of liquid throughthe first port upon contraction of the tube to its original innerdiameter.
 23. The pump of claim 22, wherein the inflatable tube furthercomprises a volume (v_(tube)) of an elastomeric material:v _(tube) =πL(2rt+t ²) and wherein the introduction of the volume ofliquid (v_(liquid)) determined according to the following equation:(12.50×v _(tube))≦v _(liquid)≦(22.16×v _(tube)) through the fill port ata fill pressure of greater than 0 and less than 35 psig expands theinflatable elastomeric tube between the mandrel and the elastomeric. 24.The pump of claim 17, wherein the mandrel comprises a radius(R_(mandrel)) and a generally uniform outer diameter that matches theoriginal inner diameter of the inflatable tube.